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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02258646




Registration number
NCT02258646
Ethics application status
Date submitted
2/10/2014
Date registered
7/10/2014
Date last updated
30/04/2019

Titles & IDs
Public title
Long-Term Integrated Telerehabilitation of COPD Patients. A Multi-Center Trial
Scientific title
Long-Term Integrated Telerehabilitation of COPD Patients. A Multi-Center Randomized Controlled Trial
Secondary ID [1] 0 0
HST1117-13
Secondary ID [2] 0 0
228919/DHE
Universal Trial Number (UTN)
Trial acronym
iTrain
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Disease, Chronic Obstructive 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - Exercise training at home
Behaviour - Telemonitoring and education/self-management

Experimental: Telerehabilitation - Exercise training at home, telemonitoring, and education/self-management

Experimental: Unsupervised exercise training at home - Unsupervised exercise training at home

No Intervention: Usual care - Usual care


Behaviour: Exercise training at home


Behaviour: Telemonitoring and education/self-management
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Combined number of hospitalizations and emergency department presentations
Timepoint [1] 0 0
Two years
Secondary outcome [1] 0 0
Hospitalizations
Timepoint [1] 0 0
Two years
Secondary outcome [2] 0 0
Emergency department presentations
Timepoint [2] 0 0
Two years
Secondary outcome [3] 0 0
Mortality
Timepoint [3] 0 0
Two years
Secondary outcome [4] 0 0
Time free from first hospitalization or emergency department presentation
Timepoint [4] 0 0
Two years
Secondary outcome [5] 0 0
Cost-effectiveness
Timepoint [5] 0 0
Two years
Secondary outcome [6] 0 0
Change from baseline in COPD Assessment Test at 6 months
Timepoint [6] 0 0
6 months
Secondary outcome [7] 0 0
Change from baseline in COPD Assessment Test at 1 year
Timepoint [7] 0 0
One year
Secondary outcome [8] 0 0
Change from baseline in COPD Assessment Test at 2 years
Timepoint [8] 0 0
Two years
Secondary outcome [9] 0 0
Change from baseline in EQ-5D at 6 months
Timepoint [9] 0 0
Six months
Secondary outcome [10] 0 0
Change from baseline in EQ-5D at 1 year
Timepoint [10] 0 0
One year
Secondary outcome [11] 0 0
Change from baseline in EQ-5D at 2 years
Timepoint [11] 0 0
Two years
Secondary outcome [12] 0 0
Change from baseline in Hospital Anxiety and Depression Scale at 6 months
Timepoint [12] 0 0
Six months
Secondary outcome [13] 0 0
Change from baseline in Hospital Anxiety and Depression Scale at 1 year
Timepoint [13] 0 0
One Year
Secondary outcome [14] 0 0
Change from baseline in Hospital Anxiety and Depression Scale at 2 years
Timepoint [14] 0 0
Two years
Secondary outcome [15] 0 0
Change from baseline in Generalized Self-Efficacy Scale at 6 months
Timepoint [15] 0 0
Six months
Secondary outcome [16] 0 0
Change from baseline in Generalized Self-Efficacy Scale at 1 year
Timepoint [16] 0 0
One year
Secondary outcome [17] 0 0
Change from baseline in Generalized Self-Efficacy Scale at 2 years
Timepoint [17] 0 0
Two years
Secondary outcome [18] 0 0
Change from baseline in 6- minute walking distance at 6 months
Timepoint [18] 0 0
Six months
Secondary outcome [19] 0 0
Change from baseline in 6- minute walking distance at 1 year
Timepoint [19] 0 0
One year
Secondary outcome [20] 0 0
Change from baseline in 6- minute walking distance at 2 years
Timepoint [20] 0 0
Two years
Secondary outcome [21] 0 0
Change from baseline in physical activity at 6 months
Timepoint [21] 0 0
Six months
Secondary outcome [22] 0 0
Change from baseline in physical activity at 1 year
Timepoint [22] 0 0
One year
Secondary outcome [23] 0 0
Change from baseline in physical activity at 2 years
Timepoint [23] 0 0
Two years
Secondary outcome [24] 0 0
Patient Global Impression of Change after 2 years
Timepoint [24] 0 0
Two years
Secondary outcome [25] 0 0
Hospitalizations at 1 year
Timepoint [25] 0 0
One year
Secondary outcome [26] 0 0
Emergency department presentations at 1 year
Timepoint [26] 0 0
One year
Secondary outcome [27] 0 0
Mortality at 1 year
Timepoint [27] 0 0
One year

Eligibility
Key inclusion criteria
- Diagnosis of COPD

- At least one COPD-related hospitalization or COPD-related emergency department
presentation in the previous 12 months to enrollment

- Capable to provide signed written informed consent
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Attendance to a rehabilitation program in the previous 6 months of enrollment

- Participation in another study that may have an impact on the outcome of this study

- Deemed by the health care team to be physically uncapable to perform the study
procedures

- Presence of comorbidities wich might prevent the patient from safely undertake an
exercise program at home

- Home environment not suitable for installation and use of rehabilitation and
monitoring equipment (e.g. physical space, Wi-FI Internet or mobile Internet via 4G)

Study design
Purpose of the study
Supportive Care
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2018
Sample size
Target
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 0 0
3181 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Denmark
State/province [1] 0 0
Esbjerg
Country [2] 0 0
Norway
State/province [2] 0 0
Tromsø

Funding & Sponsors
Primary sponsor type
Other
Name
University Hospital of North Norway
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Research Council of Norway
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
The Royal Norwegian Ministry of Health
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
LHL Helse
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
University of Tromso
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
La Trobe University
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
The Alfred
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Aalborg University
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
Hospital of South West Jutland
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
Esbjerg Municipality
Address [9] 0 0
Country [9] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This research project aims to conduct a three-arm multi-center randomized controlled trial
(RCT) on an innovative telerehabilitation intervention for patients with chronic obstructive
pulmonary disease (COPD). The overall purpose of the RCT is to demonstrate whether long-term
integrated telerehabilitation involving exercise training at home, telemonitoring, and
education/self-management will prevent hospital readmissions, thus reducing healthcare costs,
for patients with COPD, and will improve patient status and quality of life.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02258646
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paolo Zanaboni, PhD
Address 0 0
University Hospital of North Norway
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02258646